Stenosing TenosynovitisPhase 3NCT03583151
Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger
A Phase 3 study testing Amniotic fluid injection and Steroid injection in people with Stenosing Tenosynovitis, run by J&M Shuler at 1 site in United States.
Trial summary
The proposed study aims to investigate whether amniotic fluid injections are a better alternative to corticosteroid injections as a conservative treatment for stenosing tenosynovitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenosing Tenosynovitis
- What is being tested?
- Amniotic fluid injection and Steroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2018to Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is at least 18 years of age
- Patient is diagnosed with stenosing tenosynovitis
Who cannot join
- Patient is less than 18 years of age
- Pregnancy
- Enrolling clinician does not believe that the patient is mentally capable of understanding the research nature of the procedure due to mental handicap/disability or illiteracy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Injection With Amniotic Fluid Versus Corticosteroid in Patients With Stenosing Tenosynovitis: a Randomized, Blinded Trial
The proposed study aims to investigate whether amniotic fluid injections are a better alternative to corticosteroid injections as a conservative treatment for stenosing tenosynovitis. Based on results from our most recent pilot study exploring patient outcomes after receiving an amnion injection, we were able to observe symptom resolution in more than half of the study population. Adverse events were extremely rare and not related to study participation. Given the numerous occurrences of successful symptom resolution, the next step is to compare patient outcomes to those of patients who receive the standard steroid injection. This study will compare outcome measurements of patients who receive amnion injections to those who receive steroid injections.
- Conditions
- Stenosing Tenosynovitis
- Being tested
- Amniotic fluid injection, Steroid injection
- Keywords
- Corticosteroid
- Medical subject headings
- Tendon Entrapment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic fluid injectionBiological
Amniotic fluid contains various proteins that support cell proliferation, movement and differentiation. Amniotic fluid also includes collagen substrates, growth factors, amino acids, polyamines, lipids, carbohydrates, cytokines, extracellular matrix molecules like hyaluronic acid and fibronectin, cells and other chemical compounds that are needed for tissue protection and repair.
Steroid injectionBiological
Solu-medrol
| Study group | Role | What they receive |
|---|---|---|
| Steroid injection | Active comparator | 1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine Receives: Biological: Steroid injection |
| Amniotic fluid injection | Experimental | 1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine Receives: Biological: Amniotic fluid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported pain level
Analog pain scale (0-10)
Measured: 12 months
Secondary outcomes (2)
Trigger frequency
Rate at which a patient's digit will lock or trigger
Measured: 12 months
Disabilities of the Arm Shoulder and Hand score
Measure of disability in performing every day activities at work and around the house. Calculated value from DASH questionnaire.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start10 May 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosing TenosynovitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- J&M Shuler
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vivex Biomedical
- Responsible party
- Sponsor
- Investigators
- Michael Shuler, MD, Principal investigator, Athens Orthopedic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583151
- Sponsor's protocol ID
- Random TF
- Status last verified
- Jun 2018
- First submitted
- 28 Jun 2018
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection With Amniotic Fluid Versus Corticosteroid in Patients With Stenosing Tenosynovitis: a Randomized, Blinded Trial
- ClinicalTrials.gov ID
- NCT03583151
- Acronym / sponsor ID
- Random TF
- Conditions
- Stenosing Tenosynovitis
- Keywords
- Corticosteroid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- J&M ShulerIndustry (pharma, biotech, devices)
- Collaborators
- Vivex Biomedical
- Study start
- 10 May 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study aims to investigate whether amniotic fluid injections are a better alternative to corticosteroid injections as a conservative treatment for stenosing tenosynovitis. Based on results from our most recent pilot study exploring patient outcomes after receiving an amnion injection, we were able to observe symptom resolution in more than half of the study population. Adverse events were extremely rare and not related to study participation. Given the numerous occurrences of successful symptom resolution, the next step is to compare patient outcomes to those of patients who receive the standard steroid injection. This study will compare outcome measurements of patients who receive amnion injections to those who receive steroid injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid injection | Active comparator | Biological: Steroid injection1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine |
| Amniotic fluid injection | Experimental | Biological: Amniotic fluid injection1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is at least 18 years of age
- Patient is diagnosed with stenosing tenosynovitis
Key exclusion criteria (3 listed)
- Patient is less than 18 years of age
- Pregnancy
- Enrolling clinician does not believe that the patient is mentally capable of understanding the research nature of the procedure due to mental handicap/disability or illiteracy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic fluid injectionAmniotic fluid contains various proteins that support cell proliferation, movement and differentiation. Amniotic fluid also includes collagen substrates, growth factors, amino acids, polyamines, lipids, carbohydrates, cytokines, extracellular matrix molecules like hyaluronic acid and fibronectin, cells and other chemical compounds that are needed for tissue protection and repair. | Biological | Amniotic fluid injection |
| Steroid injectionSolu-medrol | Biological | Steroid injection |
Primary outcome
Patient reported pain level
Time frame: 12 months
Analog pain scale (0-10)
2 secondary outcomes
Trigger frequency
Time frame: 12 months
Disabilities of the Arm Shoulder and Hand score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Shuler, MD principal investigator
Athens Orthopedic Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amniotic fluid injection and Steroid injection in people with Stenosing Tenosynovitis, run by J&M Shuler at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported pain level (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.